Plasma Biomarkers P-DAC, V1

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT02050997
First received: January 24, 2014
Last updated: June 26, 2014
Last verified: January 2014

January 24, 2014
June 26, 2014
October 2013
December 2017   (final data collection date for primary outcome measure)
Time to disease recurrence [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ] [ Designated as safety issue: No ]
Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence
Same as current
Complete list of historical versions of study NCT02050997 on ClinicalTrials.gov Archive Site
  • Rate of progression free survival [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ] [ Designated as safety issue: No ]
    To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival
  • Accuracy, sensitivity, specificity and concordance index [ Time Frame: For the duration of study, expected 4 years ] [ Designated as safety issue: No ]
    Aim to validate a panel of predicitive plasma biomarkers proving its accuracy, sensitivity, specificity and to investigate their expression at tissue level gaining a further understanding of cancer and/or host related proteins in disease response and progression
Same as current
Not Provided
Not Provided
 
Plasma Biomarkers P-DAC, V1
Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (P-DAC Plasma Biomarker Study)

This is an exploratory, translational, non-interventional and multi-centre clinical study. The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in PDAC.

This study will involve two cohort groups, all patients involved will have PDAC.

Cohort A will involve resectable PDAC patients who will receive standard treatment of CT (with/without radiotherapy).

Cohort B will comprise of unresectable advanced PDAC patients and metastatic PDAC patients, both of whom will receive standard treatment of CT (with/without radiotherapy).

Blood samples will be taken at the following time points:

  • prior to resection, whenever feasible for cohort A
  • prior to CT, for both cohort A and B
  • during CT, for both cohort A and B
  • follow-up, approximately every 3 to 6 months for two years for cohort A
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients on this study must have pancreatic ductal adenocarcinoma.

Pancreatic Ductal Adenocarcinoma
Not Provided
  • B
    Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy
  • A
    Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Ability to give written informed consent
  • Histologically or cytologically-confirmed PDAC
  • Patients who will receive standard treatment of CT +/- radiotherapy and present with:

Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer

  • Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2

Exclusion Criteria:

  • Presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study
Both
18 Years and older
No
Ireland
 
NCT02050997
ICORG 12-31
No
ICORG- All Ireland Cooperative Oncology Research Group
ICORG- All Ireland Cooperative Oncology Research Group
Not Provided
Not Provided
ICORG- All Ireland Cooperative Oncology Research Group
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP